Patients are typically managed with bile duct stent placement to resolve/prevent malignant obstruction and jaundice. Role of radiotherapy is palliative, and involves both EBRT as well as brachytherapy. There are no prospective randomized studies to show benefit, but a number of single institution retrospective studies suggest palliative advantage. Similarly, the role of combined modality therapy is still under investigation. Photodynamic therapy appears to offer survival advantage over supportive care. Some long-term survival (20% at 4-years) with chemoradiotherapy (intraarterial 5-FU).

The role of external beam RT in this setting is not clear. There are no randomized studies; most reports are single institution retrospective analyses. Some studies show some benefit (symptom relief and survival), while other do not. Some studies also show benefit for higher dose (>45 Gy).

Conclusion: "In this hypothesis-generating analysis, the acute and chronic toxicity profile with IMRT in the treatment of pancreatic and bile duct cancer was encouraging. Local control was not compromised, despite efforts to increase conformality and avoid doses to normal structures. Distant failure remains a major obstacle in pancreatic cancer."

Conclusion: "Daily US-guided BAT targeting for patients with upper abdominal tumors was feasible in the vast majority of attempted setups. This method of US-based image-guided tumor targeting has been successfully implemented in clinical routine. The observed improved daily repositioning accuracy might allow for individualized reduction of safety margins and optional dose escalation. Compared with the established application of the BAT device for prostate radiotherapy, in which the target can be directly visualized, the TV in the present study was predominantly positioned relative to guidance vascular structures in close anatomic relation. We perceived an enormous potential in improved and individualized patient positioning for fractionated radiotherapy and also for stereotactic extracranial radiotherapy and radiosurgery, especially for tumors of the liver and pancreas."

Conclusion: "Inclusion criteria for future CRT trials should be based on tumor size at diagnosis: patients otherwise eligible for CRT should only be included with an inoperable tumor </= 40 mm, while patients with larger tumors may only benefit from palliation by stenting."

Conclusion: "3D-CRT can be considered as a valuable palliative approach for unresectabe hilar cholangiocarcinoma, and effective management of the late complications of radiotherapy play a key role in increasing survival rates of the patients."

High speed MRI to look at movement of implanted fiduciary markers during normal breathing

Movement: average 10.6mm CC, 5.2 mm lateral, 4.6 mm AP

If PTV determined during exhalation +10mm margin, CTV not covered in 19% of images

If PTV determined during inhalation +10mm margin, CTV not covered in 36% of images

Conclusion: "Four-dimensional treatment planning using high speed MRI, and integrating time and spatial information, has the potential to determine the planning target volume of moving body tumors more precisely than does conventional CT planning."

Data presented from U Michigan. Conformal high dose EBRT (48-72.6 Gy) for (HCC) and intrahepatic cholangiocarcinoma (IHCC) to potentially increase local control and survival, over what would be expected with lower dose EBRT.

Conclusion: "The appropriate dose of HA BrdU for Phase II evaluation is 25 mg/kg/day. Neither the hepatic parenchyma nor the gastrointestinal mucosa appeared to be sensitized by this method of BrdU administration. It is anticipated that these, or still newer methods of therapy, can improve treatment results in the near future."

Conclusion: "Results thus far indicate that single fractions of 18 and 22 Gy are safe to administer to liver tumors with the CyberKnife. We have not yet reached the MTD at 22 Gy. We plan to dose-escalate to 30 Gy."

Literature review is available at the Unresectable Disease/Brachytherapy page. There are several dozen retrospective single-institution studies. Overall, the trend is toward BT having some benefit in terms of obstruction, and even survival. Howerver, randomized trials are lacking.

Conclusion: "This study confirmed the role of concurrent chemoradiation in advanced biliary carcinoma; the role of intraluminal brachytherapy boost remains to be further analyzed in larger clinical trials."

Conclusion: "Combined radiotherapy and razoxane led to local response rates which are superior to data from the literature when radiotherapy alone is used. Obstacles to the treatment were complications of the disease and frequent metastasis."

Conclusion: "Inclusion criteria for future CRT trials should be based on tumor size at diagnosis: patients otherwise eligible for CRT should only be included with an inoperable tumor </= 40 mm, while patients with larger tumors may only benefit from palliation by stenting."

Conclusion: "The combination of radiotherapy, transarterial infusion chemotherapy, and concurrent infusion of a vasoconstrictor can be delivered safely with good efficacy for patients with advanced hilar duct carcinoma."

Conclusion: "Based on this study, the recommended dose for weekly short infusional gemcitabine combined with radiation therapy to the tumor and lymph nodes is 250 mg/m(2). This value is suggestive of a correlation between acute toxicity and inclusion of lymph nodes in the irradiated volume."

No variables (RT dose, chemo, grade, size) had influence on progression or OS

Conclusion: "The primary limitation of definitive chemoradiation was local progression. Although the small patient numbers limited the statistical power of this study, a suggestion of improved local control was found with the use of higher RT doses."

Conclusion: "A dose response is shown with more than double the 2-year and median survival for doses > 55 Gy. A brachytherapy dose of 25 Gy, plus 44-46 Gy external beam is well tolerated. High dose combined brachytherapy and external beam radiation (60-75 Gy) appears to be the most effective modality for extrahepatic bile duct cancer."

Conclusion: "CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy."

Conclusion: "In single-agent therapy, gemcitabine demonstrated moderate efficacy with manageable toxicity in patients with advanced or metastatic biliary tract cancer. Further evaluations are warranted, including the exact impact of gemcitabine on the management of advanced or metastatic biliary tract cancer."

Conclusion: "Weekly 24-hour gemcitabine at a dose of 100 mg/m2 is well tolerated. There was a relatively high rate of disease control for a median duration of 5.3 months (range 2.8-18.8 months). However, the objective response rate of this regimen in gallbladder and biliary tract carcinomas was limited."

Conclusion: "PDT, given in addition to best supportive care, improves survival in patients with NCC. The study was terminated prematurely because PDT proved to be so superior to simple stenting treatment that further randomization was deemed unethical."